Diacutaneous Fibrolysis and Subacromial Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01424579
First received: August 24, 2011
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain with high lifetime prevalence (one in three) in general population. In occupational population is the most common upper extremity disorder. Symptoms include pain, a variable degree of mobility limitation and a more or less pronounced functional impairment. Conservative treatment is usually the first therapeutic option and some physiotherapeutic techniques have proved its efficacy but nevertheless treatment remains challenging.

According to the investigators clinical experience, Diacutaneous Fibrolysis has a beneficial effect on patients suffering from SIS, but no one published clinical trial has evaluated this manual technique previously. The investigators hypothesis is that adding Diacutaneous Fibrolysis to a protocolized physiotherapeutic treatment can provide better outcomes. The investigators objective was to assess the effect of Diacutaneous Fibrolysis on pain, mobility and functional status in patients suffering from SIS.

A double-blind (patient and evaluator) randomized clinical trial was carried out in two public centres of Primary Health Care of the Spanish National Health System. The study protocol was approved by the Clinical Research Ethics Committee from the Jordi Gol Institute of Research in Primary Health Care and all the patients provided written consent.

A hundred and twenty patients with clinical diagnosis of SIS were included and randomly allocated to one of three groups. All groups received the same daily protocolized treatment based on therapeutic exercises, analgesic electrotherapy and cryotherapy during three weeks. Additionally, intervention group received six sessions (two a week) of actual Diacutaneous Fibrolysis; placebo group received six sessions (two a week) of placebo Diacutaneous Fibrolysis, while control group received only the protocolized treatment.

Pain intensity (VAS), active range of motion (flexion, abduction, extension, external and internal rotation) and functional status (Constant-Murley score) were measured in baseline, after the three weeks of treatment and three months after the end of treatment.


Condition Intervention
Subacromial Impingement Syndrome
Other: Actual Diacutaneous Fibrolysis
Other: Placebo Diactuaneous Fibrolysis
Other: Protocolized physiotherapeutic Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Diacutaneous Fibrolysis for the Treatment of Subacromial Impingement Syndrome: a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Changes from Baseline in Pain intensity at 3 weeks and 3 months [ Time Frame: Baseline -3 weeks - 3 months. ] [ Designated as safety issue: No ]
    Measure instrument: Visual Analogue Scale


Secondary Outcome Measures:
  • Changes from Baseline in Active Range of Motion at 3 weeks and 3 months [ Time Frame: Baseline - 3 weeks - 3 months ] [ Designated as safety issue: No ]

    Flexion, extension, abduction and external rotation movement were measured with a universal double-armed goniometer, and results are expressed in degrees.

    For Internal rotation the distance between the position achieved by the tip of the thumb in the hand-behind-back test and the inferior tip of the spinous process of C7 was measured with a flexible metric tape and results are expressed in centimeters.


  • Changes from Baseline in Functional status at 3 weeks and 3 months [ Time Frame: Baseline - 3 weeks - 3 months ] [ Designated as safety issue: No ]
    Measure instrument: Constant-Murley score


Enrollment: 120
Study Start Date: February 2008
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Actual Diacutaneous Fibrolysis
The group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of actual Diacutaneous Fibrolysis.
Other: Actual Diacutaneous Fibrolysis
Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique applied by means of a set of metallic hooks ending in a spatula with bevelled edges that allow a deeper and more precise application, which could not be achieved manually. Appropriate hook is applied following the intermuscular septum between the muscles with an anatomical or functional relationship with the painful structure, in a centripetal direction towards the pain location, in order to release adherences between musculoskeletal structures.
Other: Protocolized physiotherapeutic Treatment
Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.
Placebo Comparator: Placebo Diacutaneous Fybrolisis
This group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of placebo Diacutaneous Fibrolysis.
Other: Placebo Diactuaneous Fibrolysis
Placebo Diacutaneous Fibrolysis was applied at a superficial level and, instead of fibrolysis, a pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula, without any action taking place on the deep tissular levels.
Other: Protocolized physiotherapeutic Treatment
Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.
No Diacutaneous Fibrolysis
This group received only tree weeks of a daily protocolized treatment.
Other: Protocolized physiotherapeutic Treatment
Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Over 18 years
  • Diagnosed of Subacromial Impingement Syndrome
  • Signed a written consent form.

Exclusion criteria:

  • Damaged skin and/or cutaneous lesions in the shoulder area,
  • A concomitant treatment with platelet antiaggregant agents
  • Acute inflammatory conditions in the shoulder
  • Previous shoulder surgery
  • A pending litigation or court claim
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424579

Locations
Spain
ICS Servei de Rehabilitació Sant Ildefons
Cornellà de Llobregat, Barcelona, Spain, 08940
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
Principal Investigator: Martín Barra-López, PT Institut Català de la Salut
Study Chair: Carlos López-de-Celis, DO, PT Institut Català de la Salut
Study Chair: Gabriela Fernández-Jentsch, PT Servicio Gallego de Salud
  More Information

Additional Information:
No publications provided

Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01424579     History of Changes
Other Study ID Numbers: CEIC-P07/22
Study First Received: August 24, 2011
Last Updated: April 3, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Syndrome
Shoulder Impingement Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 19, 2014